The following data is part of a premarket notification filed by Omni Intl., Inc. with the FDA for Omnimed Nasal Oxygen Cannula.
| Device ID | K850066 |
| 510k Number | K850066 |
| Device Name: | OMNIMED NASAL OXYGEN CANNULA |
| Classification | Cannula, Nasal, Oxygen |
| Applicant | OMNI INTL., INC. 345 TACHEVAH DRIVE #9 Palm Springs, CA 92262 |
| Contact | Raman Kadevari |
| Correspondent | Raman Kadevari OMNI INTL., INC. 345 TACHEVAH DRIVE #9 Palm Springs, CA 92262 |
| Product Code | CAT |
| CFR Regulation Number | 868.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-08 |
| Decision Date | 1985-01-24 |